EUCTR2018-001587-32-DE进行中（未招募）1 期
A Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of FOLFIRINOX (FFX) versus Combination of CPI-613 with modified FOLFIRINOX (mFFX) in Patients with Metastatic Adenocarcinoma of the Pancreas - PANC003 (also known as AVENGER 500”)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •5.1.1 Histologically or cytologically confirmed metastatic Stage IV adenocarcinoma of the pancreas with relationship with to the primary tumor only.
- •5.1.2 No prior treatments for stage IV pancreatic adenocarcinoma (prior adjuvant or neoadjuvant treatment is allowed provided completed > 6 months prior to disease recurrence)
- •5.1.3 Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1
- •5.1.4 Male and female patients 18 – 75 years of age
- •5.1.5 Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
- •5.1.6 Expected survival >3 months
- •5.1.7Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted highly effective contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive(s), intrauterine hormone releasing system (IUS), bilateral tubal occlusion or vasectomized partner) during and for 6 months after last study dose and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation, at monthly interval and, at the end of systemic exposure, and at 30 days after the systemic exposure
- •5.1.8 Males with female partners (of childbearing potential) and female
- •partners (of child bearing potential) with male partners must agree to
- •use double barrier contraceptive measure (a combination of male
- •condom with either cap, diaphragm or sponge with spermicide) in
- •addition to oral contraception or avoidance of intercourse during the
- •study and for 6 months after last study dose is received
- •5.1.9 At least 2 weeks must have elapsed from any prior surgery with resolution of any sequela for randomization
- •5.1.10 Laboratory values =2 weeks prior to randomization must be:
- •- Adequate hematologic values
- •Platelet count =100,000 cells/mm3 or =100 bil/L;
- •Absolute neutrophil count [ANC] =1,500 cells/mm3 or =1.5 bil/L;
- •Hemoglobin =9 g/dL or =90 g/L)
- •- Adequate hepatic function
- •Aspartate aminotransferase [AST/SGOT] =3x upper normal limit [UNL] (=5x UNL if liver metastases present)
- •Alanine aminotransferase [ALT/SGPT] =3x UNL (=5x UNL if liver metastases present)
- •Bilirubin (=1.5x UNL); bilirubin = 2.5 x ULN for subjects with Gilbert’s syndrome
- •Serum albumin > 3.0 g/dL
- •- Adequate renal function
- •serum creatinine clearance CLcr > 30 mL/min. (Cocroft-Gault Formula should be used for CrCl calculation)
- •- Adequate coagulation function
- •International Normalized Ratio or INR must be <1.5 unless on therapeutic blood thinners)
- •5.1.11 No evidence of active infection and no serious infection within the past 30 days.
- •5.1.12 Mentally competent, ability to understand and willingness to sign the informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •5.2.1 Endocrine or acinar pancreatic carcinoma
- •5.2.2 Known cerebral metastases, central nervous system (CNS), or epidural tumor
- •5.2.3 Prior treatment with any chemotherapy for metastatic adenocarcinoma of the pancreas
- •5.2.4 Completion of a gemcitabine-based adjuvant chemotherapy regimen within less than 6 months at the time of screening.
- •5.2.5 Receipt of neoadjuvant or adjuvant FOLFIRINOX therapy if <6 months prior to disease recurrence
- •5.2.6 Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
- •5.2.7 Presence of clinically significant abdominal ascites
- •5.2.8 Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of devimistat treatment
- •5.2.9 Serious medical illness that would potentially increase patients’ risk for toxicity
- •5.2.10 Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
- •5.2.11Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of study treatment
- •5.2.12Female patients of childbearing potential with a positive pregnancy test assessed by a serum pregnancy test at screening
- •5.2.13Female patients of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for 6 months after the last dose of study treatment
- •5.2.14Male patients with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for 6 months after completion of study treatment
- •5.2.15Male patients unwilling to abstain from donating sperm during treatment and for 6 months after completion of study treatment
- •5.2.16Life expectancy less than 3 months
- •5.2.17Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
- •5.2.18Unwilling or unable to follow protocol requirements
- •5.2.19Active heart disease including but not limited to symptomatic congestive heart failure (NYHA class 3 or 4), symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction
- •5.2.20Patients with a history of myocardial infarction that is <3 months prior to registration
- •5.2.21Evidence of active infection, or serious infection within the past 30 days.
- •5.2.22Patients with known HIV infection
- •5.2.23Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of devimistat treatment (steroids given for supportive care or in response to allergic reactions are allowed at any time)
- •5.2.24Requirement for immediate palliative surgery, radiation or chemotherapy of any kind. Stenting for bile duct obstruction and need for pain medications are allowed provided all other inclusion criteria are met
- •5.2.25Prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated cancer from which the patient has been disease-free for at least 3 years prior to screening
- •5.2.26Unwilling or unable to avoid the concomitant use of strong CYP3A4 inducers or inhibitors during treatment with irinotecan
- •5.2.27A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 480 milliseconds (ms) (CTCAE grade 1) using Fredericia’s QT correction
研究者
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